Pd30-03 Predicting Response to Intravesical BCG in High Risk Non-Muscle Invasive Bladder Cancer Using an Artificial Intelligence-Powered Pathology Assay: Development and Validation in an International 12 Center Cohort

You have accessJournal of UrologyBladder Cancer: Non-invasive II (PD30)1 May 2024PD30-03 PREDICTING RESPONSE TO INTRAVESICAL BCG IN HIGH RISK NON-MUSCLE INVASIVE BLADDER CANCER USING AN ARTIFICIAL INTELLIGENCE-POWERED PATHOLOGY ASSAY: DEVELOPMENT AND VALIDATION IN AN INTERNATIONAL 12 CENTER COHORT Yair Lotan, Viswesh Krishna, Bryn Launer, Vrishab Krishna, Siddhant Singhi, Jennifer Gordetsky, Jay B. Shah, Thomas Gerald, Eugene Shkolyar, Dickon Hayne, Andrew Redfern, Lisa Spalding, Courtney Stewart, Vikram Narayan, Dattatraya Patil, Vignesh T. Packiam, Anand Rajan, Michael A. O'Donnell, Loic Baekelandt, Mario I. Fernandez, Marcela Schultz, Patrick J. Hensley, Derek B. Allison, John A. Taylor, Ameer Hamza, Vivek Nimgaonkar, Ekin Tiu, Louis J. Vaickus, Snehal Sonawane, Daniel L. Miller, Damir Vrabac, Waleed M. Abuzeid, Anirudh Joshi, Sam S. Chang, and Stephen B. Williams Yair LotanYair Lotan , Viswesh KrishnaViswesh Krishna , Bryn LaunerBryn Launer , Vrishab KrishnaVrishab Krishna , Siddhant SinghiSiddhant Singhi , Jennifer GordetskyJennifer Gordetsky , Jay B. ShahJay B. Shah , Thomas GeraldThomas Gerald , Eugene ShkolyarEugene Shkolyar , Dickon HayneDickon Hayne , Andrew RedfernAndrew Redfern , Lisa SpaldingLisa Spalding , Courtney StewartCourtney Stewart , Vikram NarayanVikram Narayan , Dattatraya PatilDattatraya Patil , Vignesh T. PackiamVignesh T. Packiam , Anand RajanAnand Rajan , Michael A. O'DonnellMichael A. O'Donnell , Loic BaekelandtLoic Baekelandt , Mario I. FernandezMario I. Fernandez , Marcela SchultzMarcela Schultz , Patrick J. HensleyPatrick J. Hensley , Derek B. AllisonDerek B. Allison , John A. TaylorJohn A. Taylor , Ameer HamzaAmeer Hamza , Vivek NimgaonkarVivek Nimgaonkar , Ekin TiuEkin Tiu , Louis J. VaickusLouis J. Vaickus , Snehal SonawaneSnehal Sonawane , Daniel L. MillerDaniel L. Miller , Damir VrabacDamir Vrabac , Waleed M. AbuzeidWaleed M. Abuzeid , Anirudh JoshiAnirudh Joshi , Sam S. ChangSam S. Chang , and Stephen B. WilliamsStephen B. Williams View All Author Informationhttps://doi.org/10.1097/01.JU.0001008848.77629.6f.03AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Intravesical BCG is first-line therapy for high-risk non-muscle invasive bladder cancer (HR NMIBC) but there are few markers to identify those likely to recur or progress. We developed and validated deep learning-based histologic assays that extract interpretable features from BCG-naïve transurethral resection of bladder tumor (TURBT) digitized pathology slides to predict recurrence and progression following BCG. METHODS: Pre-intravesical BCG TURBT-derived digital whole slide images (WSI) and clinical data were obtained for BCG-naïve AUA HR NMIBC cases diagnosed between 2000-2022 and treated with adequate BCG therapy from 12 academic centers. WSI were analyzed through a segmentation and geometric feature extraction pipeline. Features associated with high-grade recurrence free survival (hgRFS), progression free survival (PFS; upstaging and/or muscle invasion), progression to muscle invasion (mPFS) and BCG response were defined in the development cohort. Feature-locked assays were then tested on an independent validation cohort. Cases were classified into high risk (upper 20%, "AI High AI-H") and low risk (bottom 80%, "AI Low AI-L") of recurrence or progression, and on presence or absence of the BCG Unresponsive Biomarker (BUB). RESULTS: 1071 HR NMIBC cases (development: 311, validation: 760) with median follow-up of 34 months were included (HGTa:33.3%, HGT1:54.4%; any CIS:31.6%). In the validation set, patients in the AI-H group had significantly inferior hgRFS, PFS and mPFS versus the AI-L group (HR 2.32, 3.08, 3.37, p<0.001, respectively) (Fig 1). FDA-defined BCG unresponsive status was 1.8-fold higher in BUB present versus BUB absent cases. AI biomarkers were independent of age, sex, smoking status, grade, T-stage, presence of CIS and multifocality across all endpoints (p<0.001). CONCLUSIONS: In this study, we validated AI-based histologic assays that accurately identify cases of HR NMIBC that are at significantly higher risk of recurrence, progression, and development of BCG unresponsive status. These assays may aid clinical decision-making related to use of intravesical BCG versus alternative therapies in the treatment of NMIBC. Download PPT Source of Funding: None © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e625 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Yair Lotan More articles by this author Viswesh Krishna More articles by this author Bryn Launer More articles by this author Vrishab Krishna More articles by this author Siddhant Singhi More articles by this author Jennifer Gordetsky More articles by this author Jay B. Shah More articles by this author Thomas Gerald More articles by this author Eugene Shkolyar More articles by this author Dickon Hayne More articles by this author Andrew Redfern More articles by this author Lisa Spalding More articles by this author Courtney Stewart More articles by this author Vikram Narayan More articles by this author Dattatraya Patil More articles by this author Vignesh T. Packiam More articles by this author Anand Rajan More articles by this author Michael A. O'Donnell More articles by this author Loic Baekelandt More articles by this author Mario I. Fernandez More articles by this author Marcela Schultz More articles by this author Patrick J. Hensley More articles by this author Derek B. Allison More articles by this author John A. Taylor More articles by this author Ameer Hamza More articles by this author Vivek Nimgaonkar More articles by this author Ekin Tiu More articles by this author Louis J. Vaickus More articles by this author Snehal Sonawane More articles by this author Daniel L. Miller More articles by this author Damir Vrabac More articles by this author Waleed M. Abuzeid More articles by this author Anirudh Joshi More articles by this author Sam S. Chang More articles by this author Stephen B. Williams More articles by this author Expand All Advertisement PDF downloadLoading ...